Bard Put Profits Ahead of Patients’ Safety, Lawyer Says
By Jef Feeley - Aug 13, 2013 7:54 PM ET
C.R. Bard Inc. (BCR) officials put profits ahead of women’s safety when they ignored warnings about defects in some vaginal-mesh implants, a lawyer told a jury in the first federal trial of claims over the devices.
Bard officials knew the company was making implants for shoring up pelvic muscles out of plastic that carried a warning that it shouldn’t be permanently implanted in humans, and still pushed ahead with production, Henry Garrard, a lawyer for a woman suing over the devices, said in closing arguments today in Charleston, West Virginia.
“We’ve got a company here that steamrolled through safety principles,” Garrard told jurors. Bard was more concerned about generating sales of its Avaulta line of vaginal inserts than with ensuring the devices were safe, he said.
Bard, based in Murray Hill, New Jersey, faces more than 5,000 claims over its Avaulta Plus vaginal mesh, which Donna Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP) and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through vaginal incisions, degrade and shrink over time.
Many of those cases have been consolidated before U.S. District Judge Joseph Goodwin, who is presiding over Cisson’s suit in Charleston, for pretrial information exchanges. A four-woman, four-man jury is slated to begin deliberations on Cisson’s claims tomorrow.
Bard’s attorneys contend the medical-device maker properly designed and manufactured the Avaulta implants and the mesh isn’t responsible for Cisson’s injuries.
“A lot of things have been thrown out against us that aren’t grounded in science or in evidence,” Lori Cohen, one of the company’s lawyers, said in her closing argument today.
Cisson, a public-health nurse from Toccoa, Georgia, got an Avaulta Plus implant in 2009 to buttress organs that were collapsing into her pelvic region, according to evidence in the case. The 55-year-old Cisson had several surgeries to remove the mesh after she began suffering pelvic and rectal pain, bleeding and bladder spasms.
Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and painful sex linked to their products.
A California state court jury last year found Bard liable for a woman’s injuries tied to an Avaulta implant in the first case to go trial in any U.S. court. Jurors ordered the company to pay $5.5 million in damages. Bard is liable for $3.6 million of that award under state law.
In the West Virginia case, Garrard told jurors today that Bard ignored research showing plastic implanted in the human body creates a risk of erosion and infection, and used animal testing to decide if the mesh would be safe for women.
The company also disregarded a warning from a unit of Chevron Phillips Chemical Co., which made the mesh-implant’s plastic, cautioning that the material shouldn’t be implanted in humans, Garrard said.
To protect their supply of mesh plastic, Bard officials told each other in e-mails not to allow Chevron Phillips executives to learn they were using the material in people, Garrard said. “Bad ideas hurt good people and that’s what happened here,” he said.
Cohen countered that the plastic in the Avaulta implants had been safely used in medical devices for more than 50 years and experts had praised Bard’s efforts to design a way to safely reinforce failing pelvic muscles.
“There’s no one who has testified here that it is unsafe,” the company’s lawyer told the panel. Doctors concluded that Cisson’s back problems were the cause of her pelvic pain, Cohen said.
Cisson’s first trial in July ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. Goodwin ruled earlier that plaintiffs couldn’t mention that Bard had withdrawn the products.
The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).
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